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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS 5X20 INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS 5X20 INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number M003124FPP0
Device Problem Activation Failure (3270)
Patient Problem Perforation of Vessels (2135)
Event Date 07/03/2019
Event Type  malfunction  
Manufacturer Narrative
The device remains implanted in patient.
 
Event Description
It was reported that during the procedure the stent was unable to open after deployment. Therefore, a balloon exchange to expand the stent was performed which causing a perforation of the middle cerebral vessel. In addition,decompressive craniectomy was performed as a medical intervention due to the reported event. No further information is available for now.
 
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Brand NameSURPASS 5X20
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key8877123
MDR Text Key153802249
Report Number3008881809-2019-00234
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P170024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Catalogue NumberM003124FPP0
Device Lot Number19629692
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/27/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/08/2019 Patient Sequence Number: 1
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